Quality Systems

1 Unit · Graduate

Introduction to essential quality systems and the domestic and global regulatory landscape governing regulated industries. Includes a review of the historical context for the creation of the organizations that protect public health, including the Department of Health and Human Services and the Food and Drug Administration. Discusses the pivotal role of quality in determining value chains and innovation; compliance with quality systems contained within the Code of Federal Regulations (GxP and DHHS regulations), Malcolm Baldrige National Quality Award, International Organization for Standards, Total Quality Management, and International Conference on Harmonization, FDA Quality System Inspection Technique, National Committee for Quality Assurance and The Joint Commission for Accreditation of Healthcare Systems.